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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K870532
Device Name GALAXY POWERED WHEELCHAIR
Applicant
Global Research, Inc.
5618 Cr6
Hamilton,  IN  46742
Applicant Contact GARY LAUTZENHISER,SR
Correspondent
Global Research, Inc.
5618 Cr6
Hamilton,  IN  46742
Correspondent Contact GARY LAUTZENHISER,SR
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/06/1987
Decision Date 04/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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